510(k) K251212

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) by Access Vascular, Inc. — Product Code LJS

K251212 is an FDA 510(k) premarket notification submitted by Access Vascular, Inc. for the device "Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)". The FDA issued a decision of Substantially Equivalent on July 1, 2025. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Access Vascular, Inc. has at least 8 other 510(k) clearances on record.